EUCTR2019-001230-34-FI进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma(CheckMate 76K: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 76K)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,059
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a) Participants must have been diagnosed with stage IIB/C cutaneous melanoma (AJCC Staging, 8th edition) and have histologically confirmed melanoma that is completely surgically resected with documented negative margins (per local standard) for disease on resected specimens. All melanomas, except ocular and mucosal melanoma,
- •regardless of primary site of disease will be allowed.
- •b) Complete resection must be performed within 12 weeks prior to randomization. Note: In case of delays exceeding 12 weeks due to unforeseen circumstances, the eligibility should be discussed with the Medical Monitor or designee.
- •Participants must have had a negative sentinel lymph node biopsy. Participants in whom a sentinel lymph node biopsy procedure could not be done or a sentinel lymph node was not detected are not eligible.
- •c) Participants must have disease-free status documented by a complete physical examination (within 14 days) and imaging studies within 4 weeks (28 days) prior to randomization. Imaging studies must include CT scans of the chest/abdomen/pelvis or CT scan of the chest and MRI scans of the abdomen and pelvis, and all
- •known sites of resected disease (lymph nodes = 15 mm in short axis). Participants with signs and symptoms consistent with brain metastases should have imaging studies done to rule out the presence of brain metastases.
- •d) Has not been previously treated for melanoma beyond complete surgical resection of the melanoma lesion.
- •e) Has recovered adequately from toxicity and/or complications from surgery prior to study start.
- •f) ECOG performance status of 0 or 1 at the time of enrollment
- •g) Tumor tissue (minimum of 15 unstained slides or 1 FFPE block) from the resected site of disease must be provided to the central laboratory prior to randomization. If the required tumor tissue content cannot be provided, the eligibility should be discussed with the Medical Monitor or designee.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 470
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 586
排除标准
- •a) History of ocular and mucosal melanoma.
- •b) Participants with active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •c) Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- •d) Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- •e) Women who are pregnant or breastfeeding
- •f) Participants with serious or uncontrolled medical disorders.
研究者
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